Pfizer to submit NDA for breast cancer drug palbociclib later this year

US pharma giant Pfizer (NYSE: PFE) says that it will submit a New Drug Application with the US Food and Drug Administration for palbociclib, combined with letrozole, as first-line systemic treatment of post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer, early in the third quarter of this year.

This decision was based on discussions with the FDA regarding the final results of PALOMA-1, a randomized, Phase II trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. As yet, palbociclib is not approved for any indication in any market.

Last year, palbociclib received Breakthrough Therapy designation from the FDA for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer (The Pharma Letter April 11, 2013). This designation was based on interim data from the PALOMA-1 trial.